Deviation Specialist

Eupro AG; Visperterminen; Vor Ort; CHF 90.000 - 120.000; Teilzeit

Zusammenfassung

Eupro AG in Visp is seeking a Deviations Specialist to strengthen quality activities in a GMP biopharmaceutical setting. The role focuses on management, investigation and closure of deviations in a large-scale mammalian cell culture facility.

This temporary position starts early August and lasts five months. Key tasks include CAPA, root cause analysis, collaboration with SMEs, and ensuring timely deviation lifecycle compliance within a regulated environment.

Qualifikationen

• Bachelor's degree in Chemistry, Biotechnology, Life Sciences or equivalent scientific field.
• Experience in deviation management and GMP/cGMP environment within the pharmaceutical/biotech/API industry.
• Knowledge of biotechnological manufacturing processes and analytical methods.
• Experience with root cause analysis, risk management and HOP approaches is a plus.
• Excellent command of English (spoken and written); German is a plus.

Aufgaben

• Manage, investigate and close deviations in GMP biopharma.
• Identify root causes and evaluate quality impacts.
• Represent Operations in deviation processes.
• Ensure timely processing and closing of deviations.
• Write, record, and track deviations through lifecycle.
• Collaborate with SMEs and stakeholders.
• Assess impact on products, processes, equipment, or quality systems.
• Apply structured problem-solving and QRM tools.
• Define and implement CAPAs.
• Monitor CAPA effectiveness and prevent recurrence.
• Support change and process optimization projects.
• Strengthen quality culture and GMP compliance.
• Support operational improvement initiatives.

Kenntnisse

Analytical skills

Written & verbal communication

English proficiency

German knowledge

Ausbildung

Bachelor's degree in Chemistry/Life Sciences

Jobbeschreibung

For a biopharmaceutical company based in Visp and specialized in the production of biological drugs in mammalian cell culture, our team is looking for a Deviations Specialist to strengthen its quality activities in GMP environment.

-Contract : Temporary

-Start date : Beginning of August

-Duration : 5 months

Deviation Specialist 2 -Temporary position

Primary mission

The Deviations Specialist is responsible for the management, investigation and closure of deviations occurring in a GMP biopharmaceutical environment, particularly within a large-scale mammalian cell culture facility. He/she acts as the representative of Operations and ensures the identification of root causes, the evaluation of quality impacts, and the implementation of effective CAPA.

• Write, record, track, and close quality deviations.
• Ensure document compliance throughout the deviation's life cycle.
• Ensure compliance with processing and closing times.
• Conduct investigations to identify root causes and contributing factors.
• Collaborate with business experts (SME) and relevant stakeholders.
• Assess the actual or potential impact on products, processes, equipment, or quality systems.
• Use structured problem-solving methodologies (root cause analysis, quality risk management tools)
• Define and implement corrective and preventive actions.
• Establish efficiency criteria and controls.
• Monitor the execution of CAPAs to prevent recurring events.
• Participate in change and process optimization projects.
• Contribute to strengthening the quality culture and GMP compliance.
• Support operational improvement initiatives.

Profile :

• Bachelor's degree in Chemistry, Biotechnology, Life Sciences or equivalent scientific field.
• First experience in deviation management and GMP/cGMP environment within the pharmaceutical, biotechnology, or API industry, highly appreciated.
• Knowledge of biotechnological manufacturing processes and associated analytical methods.
• Experience in root cause analysis, risk management, and Human & Organizational Performance (HOP) approaches is an asset.
• Excellent command of English (spoken and written); German is a plus.
• Strong writing, analytical and communication skills.
• Organized person, rigorous, proactive and solution-oriented, able to work effectively with multidisciplinary teams in a dynamic and regulated environment.
• English: fluent (written and oral), German is a must.